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Children's Healthcare of Atlanta · 1 day ago

Research Specialist (Non-Clinical)

Brookhaven, GA

Full-time

Onsite

Mid, Senior Level

4+ years exp

Children's Healthcare of Atlanta is one of the nation’s leading children’s hospitals, committed to making kids better today and healthier tomorrow. The Research Specialist (Non-Clinical) provides oversight for all aspects of clinical research, develops and implements research processes, and ensures compliance with regulatory requirements.

ChildrenHealth CareNon Profit

Responsibilities

Develops, conducts, and facilitates research protocols at an expert level

Provides training and assistance for research protocol development, conduct, and facilitation at an expert level

May oversee some financial tasks related to research and the Clinical Research Department, such as budget preparation and compliance to budget guidelines

Provides assistance with the grant application process for program-specific grants and clinical research/trials in collaboration with appropriate personnel and ancillary departments

Collaborates with Research Administration to facilitate the pre-award process, including contract and budget routing and feasibility review

Leads others in sponsor correspondence, monitoring, and study meetings

Analyzes the feasibility of establishing new research and/or institutional protocols

Serves as a resource for facilitating grants, contracts, and financial tasks for research and clinical trials in collaboration with appropriate personnel and ancillary departments

Provides leadership and expertise in study budgeting, sponsor interactions, budget and contract routing, feasibility assessments, account management, and reconciliation

Tracks research billing to ensure research procedures are billed appropriately and resolves invoice-related issues with all parties involved

Leads participant screening, enrollment, study activities, and communication

Completes research-only testing as required and applicable per-study and system requirements, including electrocardiograms or phlebotomy (if trained to do so)

Administers various research surveys in accordance with research study requirements

Serves as a site regulatory contact for sponsored projects and assists with site initiation and monitoring visits

Develops written consent forms for protocols which conform to federal and institutional guidelines to provide patients, parents, or guardians with detailed summaries to enable informed decisions

Completes and maintains regulatory documents for all study personnel, including curriculum vitae, licenses, financial disclosures, Form FDA 1572, confidentiality agreements, training logs, and delegation of duties logs

Oversees quality monitoring and reporting activities

Initiates departmental policy and quality projects

Ensures Institutional Review Board preparation, submission, modifications, reporting, and termination activities

Works with Study Team to ensure research is conducted in compliance with local, state, and federal regulations, policies, standard operating procedures, and guidelines as well as Children’s Healthcare of Atlanta policies and guidelines

Serves as an instructor and mentor for quality and education activities

Participates in educational activities related to study needs for study staff, investigator team, and patient care staff

Leads or chairs committees or task forces

Provides leadership, training, and assistance for data management activities

Manages preparation for internal and external audit events

Works collaboratively with manager to monitor metrics and incorporate system initiatives into departmental practices

Provides back-up data entry services and ensures data integrity

Completes documentation as needed within the medical record

Qualification

Clinical research experienceStudy protocol developmentRegulatory compliance knowledgeBudget negotiation experienceMedical terminology knowledgeProject management skillsAttention to detailOrganizational skillsCommunication skillsInterpersonal skillsProblem-solving skillsSelf-motivation

Required

5 years of clinical research or 4 years of experience in clinical research with an advanced degree

Bachelor's degree in a scientific or health-related field

Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or comparable within 1 year of exam eligibility

Collaborative Institutional Training Initiative (CITI) within 30 days of employment

Demonstrates a high degree of attention to detail, with strong documentation expertise

Able to effectively multi-task and demonstrate strong organizational skills

Recognized as the Subject Matter Expert within clinical research processes and regulatory requirements

Knowledge of medical terminology

Working knowledge of applicable business systems including EPIC, CTMS, Microsoft Office, and Workday

Excellent project management skills with demonstrated ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail

Strong knowledge of federal regulations and regulatory requirements for conducting research with the ability to mentor

Self-directed and motivated to work independently toward short and long-term goals

Good written and oral communication, organization, problem-solving, and interpersonal skills